There have been questions surfacing regarding the image of the carton displayed within an SPL file. During some of the FDA webinars, the examples used have shown products that only have the principle display panel in the SPL file posted to the DailyMed website. According to FDA's XForm instructions, "Carton and container labels include the content of the Drug Facts or equivalent for animal drug products and the content of the Principal Display Panel including the image of the entire label as a single jpg file," so the full flattened out Carton needs to be included in submissions. This was later confirmed with FDA and products on the NLM may need to be revised to include the full image.
2. APIs for Import:
There are several APIs that are imported into the country for further manufacturing. There are several affirmations that accompany a product that is being imported into the country. An NDC, or Drug Listing number (DLR) is one of the affirmations. The FDA - ACS Interface Affirmation of Compliance Codes. The ACS is the automated screening of FDA regulated import entries to determine which entries to "MAY PROCEED" without FDA examination and which entries require further "FDA REVIEW". Affirmation of Compliance (AofC) codes, transmitted at the FDA line level, is one data element used in this screening process. http://www.accessdata.fda.gov/scriptS/ORA/PCB/tutorial/compliance.pdf
If this is one of the methods that products are allowed into the country, what will happen when APIs are no longer required to have an NDC number but can be included in the SPL of the finished product? Will APIs required to be part of the final SPL?
2. Export Only Products:
Discussions continued again around Drug Listing of Export Products. There is still some uncertainty on how to procede. FDA is looking into the issue.
3. Folder Naming of SPL files submitted
Each SPL file submitted to the Agency must be contained in a folder. The files submitted need to be named with the same alphanumeric GUID as the ID root. This causes confusion especially in many organizations' document repository systems. Since the folder submitted to the Agency needs to be included, it does not need to be named the same as the SPL file as some organizations may have been doing. The folder can be given a descriptive name to easily identify the SPL file being transmitted to the Agency. 4. Samples/Bulk Products in SPL
Sample and Bulk products will need to be listed in the Drug Listing section of the SPL file. Currently, these files do not reside in the How Supplied section of the content of labeling SPL file. Samples and Bulks do need to be drug listed however. Is there an issue with validation as far as listing these products but not including them within the content of labeling?
Follow up from Discussion with FDA: The regulations are not changing for drug listing or submission of content of labeling, so there are no changes to what is required for either type of submission. An SPL file can contain information about samples and bulks in the DL section of SPL, but does not need to be in the How Supplied section.
5. Delisting
FDA has extended the use of the delisting spreadsheet past June 1st. Any product that will need to be delisted can be entered onto the spreadsheet as long as it was never converted to an SPL r4 file. Files that need to be delisted in the future can be included in a spreadsheet sent to FDA and would need to specify the delisting date.
A question surfaced on what is the impact of not delisting. Update from FDA: The impact of not delisting is non-compliance with the regulations
6. Process Question Log
We are keeping a tracking log of questions related to processes so that we can bring up issues that we are faced to FDA. This list will be maintained on the WIKI so everyone can have access to it. All participants are encouraged to provide input into the question log. This is a forum for which team members can actively seek answers to questions circulating about anything related to SPL r.4, so the more questions we have, the more FAQs we will have.
7. Next meeting - March 18, 2009 at 1 PM Eastern Time.
There have been questions surfacing regarding the image of the carton displayed within an SPL file. During some of the FDA webinars, the examples used have shown products that only have the principle display panel in the SPL file posted to the DailyMed website. According to FDA's XForm instructions, "Carton and container labels include the content of the Drug Facts or equivalent for animal drug products and the content of the Principal Display Panel including the image of the entire label as a single jpg file," so the full flattened out Carton needs to be included in submissions. This was later confirmed with FDA and products on the NLM may need to be revised to include the full image.
2. APIs for Import:
There are several APIs that are imported into the country for further manufacturing. There are several affirmations that accompany a product that is being imported into the country. An NDC, or Drug Listing number (DLR) is one of the affirmations. The FDA - ACS Interface Affirmation of Compliance Codes. The ACS is the automated screening of FDA regulated import entries to determine which entries to "MAY PROCEED" without FDA examination and which entries require further "FDA REVIEW". Affirmation of Compliance (AofC) codes, transmitted at the FDA line level, is one data element used in this screening process. http://www.accessdata.fda.gov/scriptS/ORA/PCB/tutorial/compliance.pdf
If this is one of the methods that products are allowed into the country, what will happen when APIs are no longer required to have an NDC number but can be included in the SPL of the finished product? Will APIs required to be part of the final SPL?
2. Export Only Products:
Discussions continued again around Drug Listing of Export Products. There is still some uncertainty on how to procede. FDA is looking into the issue.
3. Folder Naming of SPL files submitted
Each SPL file submitted to the Agency must be contained in a folder. The files submitted need to be named with the same alphanumeric GUID as the ID root. This causes confusion especially in many organizations' document repository systems. Since the folder submitted to the Agency needs to be included, it does not need to be named the same as the SPL file as some organizations may have been doing. The folder can be given a descriptive name to easily identify the SPL file being transmitted to the Agency.
4. Samples/Bulk Products in SPL
Sample and Bulk products will need to be listed in the Drug Listing section of the SPL file. Currently, these files do not reside in the How Supplied section of the content of labeling SPL file. Samples and Bulks do need to be drug listed however. Is there an issue with validation as far as listing these products but not including them within the content of labeling?
Follow up from Discussion with FDA: The regulations are not changing for drug listing or submission of content of labeling, so there are no changes to what is required for either type of submission. An SPL file can contain information about samples and bulks in the DL section of SPL, but does not need to be in the How Supplied section.
5. Delisting
FDA has extended the use of the delisting spreadsheet past June 1st. Any product that will need to be delisted can be entered onto the spreadsheet as long as it was never converted to an SPL r4 file. Files that need to be delisted in the future can be included in a spreadsheet sent to FDA and would need to specify the delisting date.
A question surfaced on what is the impact of not delisting.
Update from FDA: The impact of not delisting is non-compliance with the regulations
6. Process Question Log
We are keeping a tracking log of questions related to processes so that we can bring up issues that we are faced to FDA. This list will be maintained on the WIKI so everyone can have access to it. All participants are encouraged to provide input into the question log. This is a forum for which team members can actively seek answers to questions circulating about anything related to SPL r.4, so the more questions we have, the more FAQs we will have.
7. Next meeting - March 18, 2009 at 1 PM Eastern Time.